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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
Generic NameTESTER, PACEMAKER ELECTRODE FUNCTION
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP980023
Supplement NumberS003
Date Received11/02/1999
Decision Date05/01/2000
Product Codes DTA DTE KRG LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for: 1) the introduction of Patient data Manager Softward, PDM 2000, and 2) a new method for determining the Use Before Date of Biotronik's ICDs.
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